Evaluating Chinese Medicine for Girls with Rapid Early Puberty
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
This study is testing a traditional Chinese medicine to see if it can help girls who are going through puberty too quickly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 8 Years to 9 Years |
| Sex | Female |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06820931 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a traditional Chinese medicine formulation, Xuandi Ziyin Mixture, in treating girls experiencing rapid progression of early puberty. It will evaluate the differential expression of specific hormones before and after diagnosis to predict the rapid progression type. The study seeks to establish standardized clinical guidelines for diagnosing and treating this condition using traditional Chinese medicine. Participants will be closely monitored for compliance and therapeutic outcomes.
Who should consider this trial
Good fit: Ideal candidates are girls aged 8 to 9 years with specific clinical signs of early puberty and good compliance.
Not a fit: Patients with disorders of gonadal development or those who have undergone treatments affecting gonadal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for girls with rapid early puberty, potentially improving their health outcomes.
How similar studies have performed: While traditional Chinese medicine approaches have been explored, this specific intervention and its efficacy in this context are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Girls with an onset age \>8 years and ≤9 years; * Breast bud Tanner stage II breast bud diameter \<3 cm; * Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm; * Bone age does not exceed actual age by more than 1 year; * LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L. * Good compliance; * Patients and their parents are willing to actively cooperate with the clinical trial; * Legal guardian signs the informed consent form. Exclusion Criteria: * Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.; * Use of treatments that affect gonadal function such as chemotherapy radiotherapy; * Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wen Sun
- Email: sunwenhere@163.com
- Phone: 8613818844692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.